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18 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING EBOOK 2021 P h a r mTe c h . c o m Manufacturing T he bio/pharmaceutical industry's response to the COVID-19 pandemic has highlighted the challenges faced in devel- oping and manufacturing a successful vaccine within a very short period of time. The efforts from pharmaceutical companies, educational establishments, and governmental and non- governmental organizations around the world that worked to find an answer to this global challenge are commendable. However, challenges remain due to the logistics of the global distribu- tion of vaccines that are unstable, highly sensitive to temperature, and require either refrigeration or deep-freeze temperatures to remain stable and effective (Table I). Advances in liquid formulations have enabled some COVID-19 vac- cines to be stored at 2–8 °C (AstraZeneca-Oxford University); however, other vaccines have extreme storage temperatures requirements like -20 °C (Moderna) or even -70 °C (Pfizer-BioNTech), bringing practical challenges during distribution and administration. Deep-freeze require- ments have even higher cold-chain logistical demands that remain a challenge for rollout, with specialist transport and storage equipment needed to keep doses of the vaccine at temperatures close to -70 °C dur- ing transport and storage before use. The common feature of all vaccines is the requirement for cold storage. A vaccine product that can be stored, distributed, and administered at ambient conditions—and have an overall longer shelf-life—would give healthcare organizations more options for distribution. Reducing vaccine waste In 2005, the World Health Organization (WHO) estimated that more than 50% of vaccines assigned to global immunization programs are Breaking the Cold Chain for Vaccines Sam de Costa Vaccine doses are often wasted due to challenges in maintaining cold storage from the manufacturing site to the patient. Aseptic spray drying offers a technology alternative to manufacture thermally stable vaccines. Sam de Costa is stabilization projects manager, Nova Laboratories Limited. VANGELIS VASSAL AKIS - STOCK.ADOBE.COM